EMPOWER-PULM (PULMonary Outcomes in Older Adults Empowered With Movement to Prevent Obesity and Weight Regain)

NCT ID: NCT03621098

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-15
• Study Completion Date: 2018-11-19

Brief Summary

The purpose of this study is to improve the understanding of the effects of weight loss on the lungs in older adults. Different types of tests to understand the effects of the EMPOWER interventions on lung function will be administered.

Detailed Description

This is a randomized clinical trial of the effects of structured aerobic exercise and a sedentary behavior intervention during weight loss on respiratory function. Site will enroll 150 older (65-85 years), obese (BMI=30-45 kg/m2), sedentary men and women from EMPOWER. EMPOWER is a 3-group design where participants will undergo a 9-month weight loss (WL) intervention (6-mo intensive phase and 3-mo reduced contact phase), followed by a 9-month self-managed follow-up phase with minimal contact. The diet element of the interventions is identical across groups, but groups differ by activity intervention: 1) moderate-intensity aerobic exercise (WL+EX); 2) intervening on SB (WL+SitLess); or 3) (WL+EX+SitLess)

Conditions

Obesity; Pulmonary Disease; Dyspnea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Diet+Exercise

Diet with structured exercise (mostly walking) at a moderate-intensity level This is not an intervention study, however, the intervention type from the parent study (EMPOWER) was behavioral (Caloric Restriction with and without Structured Exercise or Daily Activity)

No interventions assigned to this group

Diet+Daily Activity

Diet with increased light-intensity physical activity and decreased sedentary behavior throughout the day.

This is not an intervention study, however, the intervention type from the parent study (EMPOWER) was behavioral (Caloric Restriction with and without Structured Exercise or Daily Activity)

No interventions assigned to this group

Diet+Exercise+Daily Activity

Diet with structured exercise and increased daily activity. This is not an intervention study, however, the intervention type from the parent study (EMPOWER) was behavioral (Caloric Restriction with and without Structured Exercise or Daily Activity)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 65 -85 years of age
• BMI = 30-45 kg/m2
• Weight stable - no loss or gain (±5%) in past 6 months
• Sedentary
• No contraindication for safe and optimal participation in exercise training
• Approved for participation by Medical Director

Exclusion Criteria

• Dependent on cane or walker
• Reported unintentional or intentional weight loss or gain of >5% in past 6 months
• Participation in regular resistance training and/or > 20 mins/day of aerobic exercise in past 6 months
• Osteroporosis (t-score <2.3 on hip or spine scan); Severe arthritis, or other musculoskeletal disorder; Joint replacement or other orthopedic surgery in past 6 mos; joint replacement or other orthopedic surgery planned in next 2 years
• Uncontrolled resting hypertension (>160/90 mmHg);
• Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease requiring oxygen use, neurological or hematological disease,; cancer requiring treatment in past year, except non-melanoma skin cancers
• Serious conduction disorder, new Q waves or ST-segment depression (>3mm), or uncontrolled arrhythmia
• Room air SpO2 (oxygen saturation) at rest or with exercise qualifying for supplementary oxygen (SpO2≤88%)
• Abnormal kidney or liver function (2x upper limit of normal);
• eFGR < mL/min/1.73m2
• Anemia (Hb<14 g/dl in men/<12.3 g/dL in women);
• Uncontrolled diabetes (fasting blood glucose > 140 mg/dl);
• Deficient levels of vitamin D (25 hydroxyvitamin D level <20mg/mL) in those not taking a vitamin D supplement
• Smoker (No nicotine in past yr)
• No heavy alcohol use (>14 drinks/week)
• Unstable severe depression
• Regular use of: growth hormones, oral steroids, weight loss medications* or prescription osteoporosis medications*
• Current participation in other research study

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara J Nicklas, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

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Other Identifiers

IRB00041663

Identifier Type: -

Identifier Source: org_study_id